Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 27, 2024
DCA Systems HbA1c Reagent Kit
The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that …
Siemens Healthcare Diagnostics, Inc. recalled DCA Systems HbA1c Reagent Kit - a moderate-severity action.
DCA Systems HbA1c Reagent Kit was recalled by Siemens Healthcare Diagnostics, Inc. in March 27, 2024. Reason: The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias …. Check the official notice for the remedy. Verify recall #Z-1304-2024 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias ….
- Moderate
- severity level
- Class II
- classification
- March 27, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1304-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1304-2024) was formally reported on March 27, 2024, with the manufacturer initiating the action on February 7, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of Tarrytown, NY. Federal records list the affected scope as 74,211 Kits (Expanded 2/28/24: additional 72,892 kits).
The documented reason for this recall is: The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the country of Taiwan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
74,211 Kits (Expanded 2/28/24: additional 72,892 kits)
Related Recalls
6
3 from same agency
Product description
DCA Systems HbA1c Reagent Kit
Reason for recall
The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1304-2024 |
| Date reported | March 27, 2024 |
| Date initiated | February 7, 2024 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Tarrytown, NY |
| Affected scope | 74,211 Kits (Expanded 2/28/24: additional 72,892 kits) |
| Distribution | Worldwide distribution - US Nationwide and the country of Taiwan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1304-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
DCA Systems HbA1c Reagent Kit. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 74,211 Kits (Expanded 2/28/24: additional 72,892 kits).
Why was this product recalled? ▼
The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2024. Severity: Moderate. Recall number: Z-1304-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the country of Taiwan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1304-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 27, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.